Assisting HIV-infected Mothers in Disclosing Their Serostatus to Their Children

HIV Clinical Trial

— TRACK  

Official title:

Maternal HIV: Intervention to Assist Disclosure to Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00429546
• Other study ID #: R01MH077493
• Secondary ID: R01MH077493DAHBR
• Status: Completed
• Phase: Phase 1
• First received: January 29, 2007
• Last updated: June 24, 2013
• Start date: September 2007
• Est. completion date: January 2010

Study information

• Verified date: June 2013
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

This study will develop and evaluate the effectiveness of an intervention designed to assist HIV-infected mothers of young children in determining whether and how to appropriately disclose their HIV serostatus to their children.

Description:

HIV is a serious, life threatening illness that requires a lifetime of treatment and disease management. Studies have shown that it can be very difficult for infected mothers to decide whether and/or when to disclose their HIV serostatus to their uninfected children. HIV-infected parents struggle with the fear that their children will be forced to grow up too quickly, become worried or depressed, or be angry with their parents once they learn that their parents have HIV. Family-based intervention programs have been successful in helping facilitate the disclosure process. This study will develop and evaluate the effectiveness of an intervention designed to assist HIV-infected mothers of young children in determining whether and how to appropriately disclose their HIV serostatus to their children.

Participants in this study will be randomly assigned to either the intervention or a standard of care condition. The intervention will consist of three 75-minute sessions that will focus on exploring mothers' concerns, determining children's readiness to receive the news, planning for disclosure, and practicing disclosure. Participants will also receive one follow-up phone call from the therapist about 3 weeks after the last session. Sessions will be scheduled at times that are convenient for the participants and therapists. Follow-up visits will include both mothers and their children, and will be held at Months 3, 6, and 9 following the end of the intervention. Assessments will include readiness to disclose HIV serostatus, mental health indicators, and family functioning.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 65 Years

Eligibility

Inclusion Criteria:

• Confirmation of mother's HIV/AIDS status

• Healthy child (i.e., HIV uninfected) who is between 6 and 12 years of age and is unaware of maternal serostatus

• Mother is primary caregiver and child resides with her

• English- or Spanish-speaking

Exclusion Criteria:

• Child does not meet screening criteria (e.g., diagnosed with depression or suicide attempt, IQ score less than 75)

• Psychosis of parent or child (as advised by recruitment site clinicians)

• Child refuses to give assent

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor)

Related Conditions & MeSH terms

• HIV

Intervention

Behavioral:
• Teaching, Raising, and Communicating with Kids (TRACK)
TRACK is cognitive-behavioral treatment designed to improve mother-child communication and parenting skills and prepare caregiver for disclosure of HIV serostatus to child. The treatment consists of three 75-minute sessions that focus on exploring mothers' concerns, determining children's readiness to receive the news, planning for disclosure, and practicing disclosure.

Other:
• Treatment as usual
Treatment as usual includes standard care for HIV infected mothers.

Locations

Country	Name	City	State
United States	University of California, Los Angeles	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Los Angeles	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Readiness to disclose HIV serostatus		Measured at Months 3, 6, and 9	No
Primary	Disclosure of HIV serostatus		Measured at Months 3, 6, and 9	No
Secondary	Mothers' mental health indicators		Measured at Months 3, 6, and 9	No
Secondary	Children's mental health indicators		Measured at Months 3, 6, and 9	No
Secondary	Children's behavioral problems		Measured at Months 3, 6, and 9	No
Secondary	Parent-child relationship and family functioning		Measured at Months 3, 6, and 9	No